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临床试验/NCT04872205
NCT04872205已完成不适用

The Reliability and Validity of the Turkish Version of the Shanghai Elbow Dysfunction Score

Istanbul University - Cerrahpasa (IUC)1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2021年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
108
试验地点
1
主要终点
The Shanghai Elbow Dysfunction Score (SHEDS)

研究概览

简要总结

The Shanghai Elbow Dysfunction Score (SHEDS) is originally developed in English to evaluate elbow function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the SHEDS instrument into Turkish and investigate its psychometric properties.

详细描述

The Shanghai Elbow Dysfunction Score (SHEDS) is originally developed in English to evaluate joint function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the SHEDS instrument into Turkish and investigate its psychometric properties. Approximately seventy patients with elbow limitation will be included. For cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. Within a 3-to-5-day period after the first assessment, the participants will complete the Turkish version of SHEDS (SHEDS-T) to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlation with the Turkish version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, the Turkish version of Mayo Elbow Performance Score, and Short Form-12 will be determined to check the validity. Responsiveness and floor and ceiling effects will be detected.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged between 20 and 55 years
  • •Elbow fracture in the six months before the study
  • •Elbow limitation in flexion or extension
  • •Fractures should be managed with surgically
  • •Being able to follow simple instructions
  • •Being able to read and write in Turkish

排除标准

  • •Malunion or Nonunion Fracture
  • •The occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
  • •Non-healing wound or infection
  • •Previously received physiotherapy for elbow limitation
  • •Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
  • •Shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity

结局指标

主要结局

The Shanghai Elbow Dysfunction Score (SHEDS)

时间窗: Baseline (First assessment)

The Shanghai Elbow Dysfunction Score (SHEDS) is composed of 12 items and developed in 3 parts: elbow motion capacities, elbow-related symptoms, and patient satisfaction level. The SHEDS is a comprehensive and valid scoring system to evaluate elbow function in patients with elbow stiffness.

次要结局

  • The Shanghai Elbow Dysfunction Score (SHEDS)(Within a 3-to-5-day period after the first assessment (Second assessment))
  • The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire(Baseline (First assessment))
  • Mayo Elbow Performance Score (MEPS)(Baseline (First assessment))
  • Short Form-12 (SF-12)(Baseline (First assessment))

研究者

发起方
Istanbul University - Cerrahpasa (IUC)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tansu Birinci

PT, PhD

Istanbul University - Cerrahpasa (IUC)

研究点 (1)

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